Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-29 @ 5:46 PM
Study NCT ID:
NCT01236495
Status:
COMPLETED
Last Update Posted:
2012-03-13
First Post:
2010-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 mg for Post Lobectomy Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-11', 'studyFirstSubmitDate': '2010-11-05', 'studyFirstSubmitQcDate': '2010-11-05', 'lastUpdatePostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pethidine requirement', 'timeFrame': '48 hours', 'description': 'Total pethidine requirement during 48 hours postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['thoracotomy', 'postoperative pain', 'spinal morphine'], 'conditions': ['Solitary Mass', 'Lung Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the amount of total pethidine requirement during the 48 hour postoperative period after receiving spinal morphine 0.2 and 0.3 mg.', 'detailedDescription': 'Thoracotomy causes severe pain to the patients. Continuous thoracic epidural is a gold standard for postoperative pain. However, it needs skill. There are many alternatives such as spinal morphine, intercostal nerve block, cryoalangesia or interpleural block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 year and \\< 70 year\n* Patient ASA physical status I-III.\n* Scheduled for thoracotomy with lobectomy.\n* Can operate a patient-controlled analgesia (PCA) device.\n\nExclusion Criteria:\n\n* Known hypersensitivity to morphine or pethidine\n* History of bleeding tendency.\n* Known case of infection at the back\n* Patient refuse for spinal anesthesia\n* History of cerebrovascular disease.\n* Scheduled for video-assisted thoracoscopic lobectomy.\n* Need mechanical ventilatory support during postoperative period'}, 'identificationModule': {'nctId': 'NCT01236495', 'acronym': 'pain', 'briefTitle': 'Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 mg for Post Lobectomy Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 Milligram for Post Lobectomy (Lung) Analgesia', 'orgStudyIdInfo': {'id': 'si578/2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'spinal morphine 0.2 mg', 'description': 'spinal morphine 0.2 mg', 'interventionNames': ['Drug: spinal morphine 0.2 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'spinal morphine 0.3 mg', 'description': 'spinal morphine 0.3 mg', 'interventionNames': ['Drug: spinal morphine 0.3 mg']}], 'interventions': [{'name': 'spinal morphine 0.3 mg', 'type': 'DRUG', 'otherNames': ['morphine'], 'description': 'spinal morphine 0.3 mg', 'armGroupLabels': ['spinal morphine 0.3 mg']}, {'name': 'spinal morphine 0.2 mg', 'type': 'DRUG', 'otherNames': ['morphine'], 'description': 'spinal morphine 0.2 mg', 'armGroupLabels': ['spinal morphine 0.2 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine, Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Sirilak Suksompong, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deaprt ment of Anesthesiology ,Faculty of Medicine, Siriraj Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sirilak Suksompong', 'investigatorAffiliation': 'Mahidol University'}}}}